BRINTELLIX

Country: Ինդոնեզիա

language: ինդոնեզերեն

source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

active_ingredient:

VORTIOXETINE HBR

MAH:

PYRIDAM FARMA TBK - Indonesia

INN:

VORTIOXETINE HBR

dosage:

10 MG

pharmaceutical_form:

TABLET SALUT SELAPUT

units_in_package:

DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT

manufactured_by:

H. LUDBECK A/S - Denmark

authorization_date:

2017-10-19

SPC

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.

INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS, AND YOUNG ADULTS TAKING ANTIDEPRESSANTS (5.1).

MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS
AND BEHAVIORS (5.1).

BRINTELLIX HAS NOT BEEN EVALUATED FOR USE IN PEDIATRIC
PATIENTS (8.4).
BRINTELLIX
®
FILM-COATED TABLETS
VORTIOXETINE (AS HYDROBROMIDE)
1.
NAME OF THE MEDI CINAL PRODUCT
Brintellix 5 mg film-coated tablets
Brintellix 10 mg film-coated tablets
Brintellix 20 mg film-coated tablets
2.
QUALITATIVE AND Q UANTITATIVE COMPOSITION
Brintellix 5 mg film-coated tablets
Each film-coated tablet contains vortioxetine hydrobromide equivalent
to 5 mg
vortioxetine.
Brintellix 10 mg film-coated tablets
Each film-coated tablet contains vortioxetine hydrobromide equivalent
to 10 mg
vortioxetine.
Brintellix 20 mg film-coated tablets
Each film-coated tablet contains vortioxetine hydrobromide equivalent
to 20 mg
vortioxetine.
For the full list of excipients, see section 6.1.
DISETUJUI OLEH BPOM: 29/12/2021
EREG10019312100276
EREG10019312100277
EREG10019312100278
3.
PHARMACEUTICAL FORM
Film-coated tablet.
B
rintellix 5 mg film-coated tablets
Pink, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with
“TL” on one side
and “5” on the other side.
Brintellix 10 mg film-coated tablets
Yellow, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with
“TL” on one
side and “10” on the other side.
Brintellix 20 mg film-coated tablets
Red, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with
“TL” on one side
and “20” on the other side.
4.
CLINICAL PARTICUL ARS
4.1
TERAPEUTIC INDICATIONS
Brintellix is indicated for the treatment of major depressive disorder
in adults. The
efficacy of Brintellix was demonstrated in 6 to 8 week studies
(including one study in
the elderly).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology (tablet)
The starting and recommended dose of Brintellix is 10 mg vortioxetine
on